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New treatment option for Peritoneal Carcinoma Metastatic
Official title Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors
ClinicalTrials.gov ID: NCT04684459
What this study is testing
What is Dual-targeting HER2 and PD-L1 CAR-T cells?
Dual-targeting HER2 and PD-L1 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peritoneal carcinoma metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- CAR-T therapy has achieved unprecedented success in hematological tumors in recent years, but the progress of CAR-T cells in the treatment of solid tumors is facing difficulties. HER-2 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female, Age 18-75 years old; If the people are over 75 years old, the researchers will determine whether to enroll according to the basic...
- Estimated life expectancy ≥ 3 months (according to investigator's judgement);
- The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
- Patients diagnosed as ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, head and neck cancer, pancreatic cancer, colorectal...
- Expressing HER2 \>20% of primary tumors or metastatic cells in the serous cavity by immunohistochemistry (IHC) or fluorescence in situ hybridization...
You likely can't join if
- Allergic to cytokines;
- Uncontrolled activity infection;
- Acute or chronic (graft-versus-host disease) GVHD;
- Accompanied by other uncontrolled malignant tumors;
- Patient with hepatitis B or C active period, HIV infection ≥ the upper limit of the normal level;
- Suffer from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral...
See the full eligibility criteria
- Male or female, Age 18-75 years old; If the people are over 75 years old, the researchers will determine whether to enroll according to the basic health conditions of the people, regardless of gender. No upper age limit...
- Estimated life expectancy ≥ 3 months (according to investigator's judgement);
- The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
- Patients diagnosed as ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, head and neck cancer, pancreatic cancer, colorectal cancer, transitional cell carcinoma, endometrial carcinoma, sarcoma...
- Expressing HER2 \>20% of primary tumors or metastatic cells in the serous cavity by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH);
- Absolute neutrophil count ≥ 1×10\^9/L, platelet count ≥ 75×10\^9/L, absolute lymphocyte count ≥0.5×10\^8/L, hemoglobin ≥ 8.0 g/dl;
- Creatinine clearance rate ≥60ml/min, Serum ALT/AST≤2.5 times of the normal level, and total bilirubin≤1.5 times of the normal level;
- Cardiac ejection fraction ≥50%, no pericardial effusion;
- No other serious diseases (autoimmune diseases or any immune deficiency disease or other disease in need of immunosuppressive therapy);
- Patients must stop chemotherapy and targeted therapy for at least 3 weeks before starting treatment;
- Patients must take reliable contraceptive measures before entering the trial, during the research process until 1 year after CAR-T infusion; reliable contraceptive measures will be determined by the main investigator or...
- Voluntarily participate in the research, understand and sign the informed consent;
- The side effect of the last anti-tumor treatment was reduced to ≤1 grade, except for hair loss.
- Allergic to cytokines;
- Uncontrolled activity infection;
- Acute or chronic (graft-versus-host disease) GVHD;
- Accompanied by other uncontrolled malignant tumors;
- Patient with hepatitis B or C active period, HIV infection ≥ the upper limit of the normal level;
- Suffer from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.;
- Patients with grade 2-3 hypertension or poorly controlled;
- History of mental illness that is difficult to control;
- Patients have used immunosuppressive agents for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;
- The existing medical history or mental state history or laboratory abnormalities may increase the risk associated with participating in the study or the administration of the study drug;
- Unstable pulmonary embolism, deep venous embolism or other major arterial/venous thromboembolic events occurred within 6 months before enrollment. If receiving anticoagulant therapy;
- Pregnant or nursing women, or plan to become pregnant during the treatment period or within 1 year after the treatment ends;
- Patient suffering from diseases that have signed written informed consent or comply with research procedures; or are unwilling or unable to comply with research requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.